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Clinical Trial Record

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Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas

1999-03

N/A

N/A

41

Study Overview

Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.

OBJECTIVES: * Determine the response rate and survival of patients with metastatic pancreatic cancer and overexpression of HER2/neu treated with gemcitabine and trastuzumab. * Determine the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes once weekly during weeks 1-7. Patients receive trastuzumab IV over 90 minutes once during week 1 and trastuzumab IV over 30-90 minutes once weekly during weeks 2-8. Patients with stable or responding disease receive gemcitabine IV over 30 minutes once weekly during weeks 1-3 and trastuzumab IV over 30 minutes once weekly during weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A maximum of 41 patients will be accrued for this study over 18-24 months.

  • Pancreatic Cancer
  • BIOLOGICAL: trastuzumab
  • DRUG: gemcitabine hydrochloride
  • CDR0000066940
  • BRUOG-PA-77
  • NCI-T98-0067

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

1999-11-01  

N/A  

2013-12-18  

2003-05-01  

N/A  

2013-12-19  

2003-05-02  

N/A  

2002-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/Treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    DISEASE CHARACTERISTICS:

  • Histologically proven metastatic pancreatic cancer with overexpression of HER2/neu
  • Patients in whom there is inadequate tissue to evaluate for HER2/neu overexpression but who have elevated serum HER2/neu antigen levels are eligible
  • Radiographically measurable disease


  • May have metastatic disease in which primary lesion is measurable but metastatic lesions are not measurable
  • Ascites is not measurable

    • PATIENT CHARACTERISTICS:
    Age:

  • Over 18

    • Performance status:

  • ECOG 0-2

    • Life expectancy:

  • Not specified

    • Hematopoietic:

  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

    • Hepatic:

  • Bilirubin no greater than 3.0 mg/dL


  • Greater than 3 times normal if increase in bilirubin is due to biliary obstruction from tumor as long as biliary system is stented or bypassed and bilirubin, SGOT, or SGPT is stable or decreasing
  • SGOT no greater than 3 times normal


  • No greater than 5 times normal if liver metastases present OR
  • Greater than 5 times normal if increase in SGOT or SGPT is due to biliary obstruction from tumor as long as biliary system is stented or bypassed and biliary SGOT or SGPT is stable or decreasing

    • Renal:

  • Creatinine no greater than 2.0 mg/dL

    • Cardiovascular:

  • No unstable angina
  • No prior congestive heart failure
  • No prior myocardial infarction
  • LVEF at least 45% by MUGA or echocardiogram

    • Other:

  • Not pregnant
  • Fertile patients must use effective contraception

    • PRIOR CONCURRENT THERAPY:
    Biologic therapy:

  • No prior trastuzumab
  • No concurrent growth factors

    • Chemotherapy:

  • No prior anthracyclines
  • No prior gemcitabine except prior low dose (no greater than 300 mg/m2/week) gemcitabine with radiotherapy
  • At least 6 months since prior adjuvant therapy
  • More than 2 weeks since other prior chemotherapy
  • No other concurrent cytotoxic chemotherapy

    • Endocrine therapy:

  • Not specified

    • Radiotherapy:

  • See Chemotherapy
  • More than 2 weeks since prior radiotherapy
  • No concurrent radiotherapy

    • Surgery:

  • Not specified

    • Other:

  • No other concurrent investigational agents

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • National Cancer Institute (NCI)
  • STUDY_CHAIR: Howard Safran, MD, Brown University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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